To ask the Secretary of State for Health and Social Care, what safeguards his Department has put in place to ensure that medical Serious Shortage Protocols do not pose risk to the well-being of patients.

The Department engaged with a wide range of stakeholder representative bodies about the proposals and also conducted a written consultation. The Department received 47 responses to its written consultation including from industry, patients’, pharmacists’ and doctors’ representative bodies. The responses to the consultation were broadly supportive.

The Statutory Instrument is expected to be laid shortly and come into force before 29 March. Any serious shortage protocol would be developed with and signed off by clinicians. Only if clinicians deem it appropriate, an alternative quantity, strength, pharmaceutical form or medicine can be dispensed in line with the protocol.

A protocol is only one of the tools that can be used to manage shortages. The Department manages shortages in collaboration with manufacturers and suppliers, the National Health Service and the Medicines and Healthcare products Regulatory Agency and will continue to do so. A protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate, taking account of the risks to and well-being of patients and after discussion with the manufacturer and/or marketing authorisation holder.

Any serious shortage would be time limited and the protocol itself would indicate the period during which it has effect.